We are seeking an experienced Clinical Research Program Manager to lead the planning, development, and execution of complex clinical trials or programs. This role provides both strategic oversight and hands-on leadership, managing study operations/finances, supervising clinical research staff, and ensuring compliance with protocol, regulatory requirements, and patient care standards.
The ideal candidate brings a strong background in clinical research operations and finances, team leadership, and patient-centered care, with the ability to manage multiple priorities in a fast-paced environment.
Key Responsibilities:
Clinical Trial Leadership & Operations
- Lead the planning, development, and implementation of clinical trial protocols, procedures, and operational systems in collaboration with the Principal Investigator
- Oversee day-to-day clinical trial activities to ensure efficient workflow, protocol adherence, and high-quality patient care
- Establish and manage data collection systems; oversee the accurate collection, processing, and reporting of clinical data and specimens
Team Management & Supervision
- Recruit, supervise, train, and evaluate clinical research staff
- Ensure all clinical and research activities comply with protocol requirements, clinical standards, and safety regulations
- Set priorities, manage workloads, and foster a collaborative, high-performing team environment
Patient Care & Recruitment
- Oversee participant recruitment, screening, enrollment, and retention strategies
- Provide direct patient care and perform clinical procedures as appropriate
- Educate research participants on study protocols, treatments, and investigational products
Finance, Resources & Budget Administration
- Develop and manage study budgets, resource plans, and operational needs
- Coordinate procurement and setup of clinical facilities, equipment, and supplies
- Maintain database that contains records related to patient incentives, inventory, and study documentation
Regulatory Compliance & Reporting
- Ensure compliance with all applicable federal, state, and institutional regulations
- Maintain complete and accurate source documentation and study records
- Prepare reports and communicate study progress, outcomes, and patient responses to investigators, sponsors, and regulatory bodies
Stakeholder Collaboration & Strategy
- Serve as a liaison between investigators, departments, sponsors, and regulatory agencies
- Support audits, identify operational challenges, and implement corrective actions
- Contribute to grant writing, funding proposals, and long-term research planning
- Represent and promote research initiatives to internal and external stakeholders
Core Competencies
- Excellent interpersonal, leadership, and communication skills
- Ability to manage competing priorities and make sound decisions in a fast-paced environment
- Strong organizational and problem-solving abilities
- High level of professionalism when handling sensitive and confidential information
- Ability to design and implement systems for data collection, tracking, and analysis
See the Position Description for additional information.
